A novel device for left atrial appendage exclusion: the third-generation atrial exclusion device.
OBJECTIVE
Occlusion of the left atrial appendage is proposed to reduce the risk of stroke in patients with atrial fibrillation. The third-generation atrial exclusion device, modified to provide uniform distribution of pressure at appendage exclusion, was assessed for safety and effectiveness in a canine model and compared with a surgical stapler.


METHODS
The atrial exclusion device consists of 2 parallel, straight, rigid titanium tubes and 2 nitinol springs with a knit-braided polyester fabric. Fourteen mongrel dogs were implanted with the device at the base of the left atrial appendage via a median sternotomy. In each dog, the right atrial appendage was stapled with a commercial apparatus for comparison. The animals were evaluated at 7 days (n = 3), 30 days (n = 5), and 90 days (n = 6) after implantation by epicardial echocardiography, left atrial and coronary angiography, gross pathology, and histology.


RESULTS
Left atrial appendage exclusion was complete and achieved without hemodynamic instability, and coronary angiography revealed that the left circumflex artery was patent in all cases. A new endothelial tissue layer developed on the occluded orifice of the left atrium 90 days after implantation. This endothelial layer was not evident on the stapled right atrial appendage.


CONCLUSIONS
In dogs, the third-generation atrial exclusion device achieved easy, reliable, and safe exclusion of the left atrial appendage with favorable histologic results. Clinical application could provide a new therapeutic option for reducing the risk of stroke in patients with atrial fibrillation.
Fumoto
Hideyuki
H
Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA.
Gillinov
A Marc
AM
Ootaki
Yoshio
Y
Akiyama
Masatoshi
M
Saeed
Diyar
D
Horai
Tetsuya
T
Ootaki
Chiyo
C
Vince
D Geoffrey
DG
Popović
Zoran B
ZB
Dessoffy
Raymond
R
Massiello
Alex
A
Catanese
Jacquelyn
J
Fukamachi
Kiyotaka
K
D000704:Analysis of Variance; D000792:Angiography; D000818:Animals; D020517:Atrial Appendage / Q000473:pathology / Q000601:surgery*; D001281:Atrial Fibrillation / Q000517:prevention & control*; D004195:Disease Models, Animal; D004285:Dogs; D015150:Echocardiography, Doppler; D006439:Hemodynamics / Q000502:physiology; D007150:Immunohistochemistry; D020097:Natriuretic Peptide, Brain / Q000378:metabolism; D011336:Probability; D019736:Prostheses and Implants; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods; D011897:Random Allocation; D012680:Sensitivity and Specificity; D020521:Stroke / Q000517:prevention & control*; D013525:Surgical Instruments
D020097:Natriuretic Peptide, Brain